2. Conscious Sedation: What You Need to Know Michael Sugarman, MD Visiting Professor of Anesthesiology Montefiore Medical Center Albert Einstein College of Medicine

3. Conscious Sedation 4 Introduction 4 New JCAHO Standards are here! 4 How to... 4 Continuum of Sedation 4 Medications 4 Quality/Risk Management

4. “Conscious SeaDation”

5. JCAHO JCAHO (Joint Commission on Accreditation of Healthcare Organizations) directs institutions to develop individual policies, protocols and procedures and provides direction for the content.

6. JCAHO Standards 4 Pre-procedure Medical Evaluation 4 Informed Consent 4 Credentials of Personnel 4 Qualified Staff Present 4 Necessary Equipment 4 Required Documentation 4 Recovery 4 Quality Management System

7. JCAHO Scoring of Institutions 4 Has the patient received proper informed consent? 4 Has the patient received a proper pre- procedure medical evaluation? 4 Is moderate or deep sedation provided by qualified individuals? 4 Are sufficient numbers of qualified personnel available to perform the procedure and monitor the patient?

8. JCAHO Scoring(Continued) 4 Is appropriate equipment available to monitor the patient’s heart rate, respiratory rate, and oxygenation? 4 Is each patient’s status monitored while undergoing moderate or deep sedation and documented in the medical record? 4 Are outcomes of patients undergoing moderate or deep sedation collected and analyzed?

9. How to... 4 Logistics 4 Patient Evaluation 4 Equipment & Monitoring 4 Managing Complications 4 Recovery

10. Credentials 4 Procedural sedation must be administered by or under supervision of a credentialed member of the staff 4 Appropriate supporting personnel in attendance. 4 The protocol should describe: 4Training Requirements 4Experience Requirements 4Demonstration of capability in resuscitation and emergency airway management.

11. Staffing 4 The minimum number of staff required to conduct procedural sedation is two, the operator and a qualified assistant to monitor and provide supportive care of the patient.

12. Equipment 4 Oxygen 4 Airway rescue equipment 4 Suction 4 Defibrillator 4 Blood pressure 4 EKG 4 Pulse oxymetry

13. Monitoring  Record at intervals  15 minutes 4Time of day 4Pulse and respiratory rates 4Oxygen saturation 4Level of consciousness 4Dose of each medication administered 4 These will be recorded minimally at pre- and post-procedure.

14. Patient Evaluation 4Patient interview to review: 4Medical history 4Anesthesia history 4Medication history 4NPO Status 4Appropriate physical examination 4Review of objective diagnostic data (e.g., laboratory, ECG, X-ray) 4Formulation and discussion of a plan with the patient and/or responsible adult

15. Informed Consent 4 Informed consent is to be obtained by a physician or his/her designee and the record will reflect that the patient was informed of the indications for and accepted the risks associated with procedural sedation 4 The plan of care must be discussed with and approved by an Attending physician.

16. Recovery and Outcomes 4 Post-procedure and sedation monitoring and evaluation should indicate the elements of decision-making leading to return to routine nursing care, transfer or discharge of each patient. 4 Outcomes should be collected and analyzed for quality of care.

17. Continuum of Sedation 4 Minimal Sedation (Anxiolysis) 4 Light Sedation/Analgesia (Conscious Sedation) 4 Deep Sedation/Analgesia 4 General Anesthesia

18. Managing the Continuum 4 Not always possible to predict how an individual will respond 4 Practitioners intending to produce a given level of sedation should be able to rescue patients whose level of sedation becomes deeper than initially intended

19. Minimal Sedation (Anxiolysis) 4 Drug-induced state 4 Normal response to verbal commands 4 Cognitive function may be impaired 4 Coordination may be impaired 4 Cardiovascular function unaffected 4 Respiratory function unaffected

20. Moderate Sedation/Analgesia (Conscious Sedation) 4 Drug-induced depression of consciousness 4 Purposeful response to verbal commands 4 Reflex withdrawal from pain persists 4 Impairment of independent ventilatory function 4 Cardiovascular function is usually maintained

21. Deep Sedation/Analgesia 4 Drug-induced depression of consciousness 4 Difficult to arouse 4 Respond purposefully following repeated or painful stimulation 4 Ability to maintain ventilatory function independently may be compromised 4 Cardiovascular function is usually maintained

22. General Anesthesia 4 Drug-induced loss of consciousness 4 Cannot be aroused following repeated or painful stimulation 4 Ventilatory function is often impaired with patients often requiring assistance in maintaining a patent airway

23. General Anesthesia (Continued) 4 Positive pressure ventilation may be necessary because neuromuscular function may be depressed 4 Cardiovascular function may be impaired

24. Continuum of Depth of Sedation ** reflex withdrawal from a painful stimulus is NOT a purposeful response

25. Rescue 4 Individuals administering Moderate Sedation/Analgesia should be able to rescue patients who enter a state of Deep Sedation/Analgesia 4 Individuals administering Deep Sedation/Analgesia should be able to rescue patients who enter a state of General Anesthesia

26. Managing Complications 4 Light Sedation vs. Deep Sedation 4 Hypotension - NPO effects 4 Hypertension 4Anxiety 4Pain  Bladder Distention 4 Cardiac Dysrhythmias

27. Managing Complications (Continued)  Respiratory Compromise 4Narcotic Induced  Benzodiazepine Induced  Upper Airway Obstruction  Bronchospasm  Laryngospas m 4 Nausea and Vomiting

28. Recovery 4 Loss of procedural stimulation 4 Oxygen therapy immediately available 4 Urinary Retention 4 Ability to take PO

29. Discharge Criteria 4 Adequate respiratory function 4 Level of consciousness 4 Intact protective reflexes 4 Vital signs stable 4 Mobility consistent with pre-procedural level 4 Satisfactory skin color and condition/peripheral circulation

30. Discharge Criteria (Continued) 4 Acceptable nausea/vomiting status 4 Acceptable pain management 4 Stable operative area 4 Understanding by patient and/or significant other of Discharge Instructions

31. Medications 4 Sedatives 4 Narcotics 4 Reversal Agents

32. Sedatives

33. Sedatives (Continued)

34. Other Sedatives (Induction Agents) 4 Propofol 4Achieve deep sedation quickly 4Apnea occurs frequently 4Rapid passage to general anesthesia 4 Ketamine 4Produces a dissociative state with profound analgesia 4Copious secretions 4Emergence delerium

35. Narcotics

36. Narcotics (Continued)

37. Reversal Agents

38. Reversal Agents (Continued)

39. Quality Management 4 Risk Management 4 Quality Management 4Reporting 4Sample Indicators

40. Risk Management 4 Mechanisms to Reduce Medical Malpractice Related to the Administration of Conscious Sedation 4Education, Preparation & Requirements for the Conscious Sedation Providers 4Quality Management Database 4Data Driven Continuous Quality Improvement

41. Quality Improvement Monitoring and Reporting 4 The clinical department must regularly reviews 4 Quality indicator thresholds should be specifically established 4 Clear corrective processes should be established when these thresholds have been exceeded 4 Quality Reports will be completed and forwarded to the Quality Office when any of the pre-determined adverse outcome criteria are met

42. Sample Components of a Conscious Sedation Database 4 ANY use of a Reversal Agent 4 ANY patient requiring Assisted Ventilation (Bag Breathing) 4 ANY new cardiac arrhythmia 4 ANY desaturation of O2 below 90% sustained for 5 minutes

43. More Sample Components of a Conscious Sedation Database 4 ANY decrease of VS by 30% 4 ANY failure to return to baseline 4 ANY case with unplanned admission resulting from sedation 4 ANY case wherein review is thought to be beneficial